Kornimate/medical-research-clean huggingface dataset:
stp.168 clinical study protocol parakeet

Conditions: Parathyroid; Anomaly; Parathyroid Dysfunction; Hyperparathyroidism; Parathyroid Gland Adenoma

Summary: study purpose the purpose of this study is to demonstrate the performance of the parakeet rapid parathyroid testing kit by comparing parakeet results with histopathologic diagnosis. study objectives to demonstrate the positive percent agreement (ppa) and negative percent agreement (npa) of the parakeet rapid parathyroid testing kit test results in fna from excised tissue during parathyroid surgery with pathologic diagnosis.

the parakeet is a lateral flow cassette designed to aid in the detection of parathyroid gland by identifying tissue with parathyroid hormone levels \> 60 pg./ml in a fine needle aspirate specimen. the fna specimen of the target tissue is combined with running fluid and deposited into the sample well of a lateral flow cassette. lateral flow occurs and the test line begins to darken within minutes if pth is present in quantities \> 60 pg./ml. at 5 minutes, a full visualization of the tl is done. a negative test (\< 60 pg./ml of pth in the sample) shows darkening of the control line only. absence of control line development indicates a defective test kit. intended use the parakeet rapid parathyroid testing kit is an immunoassay lateral flow cassette intended to detect qualitative differences in extracellular concentration of parathyroid hormone in excised samples suspected of being parathyroid glands as an adjunct to current clinical methods, including histopathology, to locate the parathyroid glands. indications for use the parakeet rapid parathyroid testing kit is indicated for use in adult patients where location of the parathyroid glands is medically necessary, such as in patients undergoing parathyroidectomy for hyperparathyroidism.

Eligibility criteria:
inclusion criteria: men and women ≥18 years of age scheduled for parathyroid surgery exclusion criteria: unable or unwilling to provide informed consent subject has any condition that in the opinion of the investigator should preclude participation in the study

Keywords: immunoassay lateral flow, parathyroid gland, pth, fna parathyroid gland, pth, fna
bioflow-iii canada satellite registry

Conditions: Coronary Artery Disease; Myocardial Ischemia

Summary: for the majority of coronary artery disease (cad), treatment with percutaneous transluminal coronary angioplasty (ptca) provides high initial procedural success. however, the medium to long-term complications range from rather immediate elastic recoil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. the reported incidence of restenosis after ptca ranges from 30%-50%. such rates of recurrence have serious economic consequences. bare metal stents (bms), designed to address the limitations of ptca, reduced the angiographic and clinical restenosis rates in de novo lesions compared to ptca alone and decreased the need for cabg. bms substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures. the invention of drug eluting stents (des) significantly improved on the principle of bms by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. the introduction of des greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to bms with systemic drug administration. these advantages and a lower cost compared to surgical interventions has made des an attractive option to treat coronary artery disease. this observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the orsiro drug eluting stent system in an all-comers patient population in daily clinical practice.


Eligibility criteria:
inclusion criteria: * symptomatic coronary artery disease or documented silent ischemia * subject informed consent for data release * subject is geographically stable and willing to participate at all follow ups assessments exclusion criteria: * subject did not sign informed consent for data release * pregnancy * known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation/antiplatelet therapy required for pci, stainless steel, sirolimus * planned surgery within 6 months of pci unless dual antiplatelet therapy will be maintained

Keywords: international multicenter observational registry orsiro drug eluting stent (des) stenting treatment of coronary artery disease coronary revascularization percutaneous coronary intervention (pci) stemi nstemi ischemia angina subgroups acute myocardial infarction diabetes small vessels chronic total occlusion (cto)
intravenous treatments used in medication overuse headache bridge treatment

Conditions: Medication Overuse Headache

Summary: medication overuse headache is the chronicity of headaches, which occurs more than 15 days a month, as a result of frequent use of painkillers, opioids or migraine attack drugs (ergotamine, triptan) in individuals with pre-existing primary headache disease. in the treatment of this headache, two ways can be followed as slow drug discontinuation or sudden drug discontinuation. the most commonly used method is the sudden discontinuation of the overused analgesic agent, the initiation of prophylactic treatment, and then the application of bridge therapy for 6-10 days. intravenous hydration, steroids, antiemetics, neuroleptic drugs and local anesthetic drugs such as lidocaine can be used in bridge treatment.

in our clinic, we routinely apply intravenous 1.5 mg/kg lidocaine, intravenous prednisolone and intravenous saline treatments as bridge treatment to patients diagnosed with medication overuse headache. in this study, we aimed to compare the efficacy of intravenous lidocaine, intravenous steroids and intravenous hydration therapy, which were used as bridge therapy after the cessation of analgesic use in patients with medication overuse headache. patients who applied to the algology outpatient clinic and who were diagnosed with drug overuse headache and treated were evaluated by dividing them into 3 different groups. it was planned to include 15 patients in each group. the first group consists of patients who were given 500 cc of intravenous saline for 1 hour in the service. the second group consisted of patients who were given 80 mg intravenous prednisolone for the first 4 days and then gradually reduced doses of prednisolone in the following days. the third group includes patients in whom 2 mg/kg intravenous lidocaine was administered as a 1-hour infusion, monitored in the ward. pain intensity will be evaluated by visual analog scale (vas) in all patients after treatment, at 1 month and 3 months. in addition, the number of days with pain and the number of analgesics used in the 3-month period after the end of the treatment will be evaluated and the quality of life scale will be applied.

Eligibility criteria:
inclusion criteria: * medication overuse headache * chronic migraine exclusion criteria: * other headaches will not accompany (tension-type headache, cluster...) * pregnancy * epilepsia * heart disease * bradikardia * hypertension * diabetes mellitus

Keywords: lidocaine prednisolone intravenous hydration
rituximab trial for pediatric nephrotic syndrome

Conditions: Steroid Resistant Nephrotic Syndrome; Steroid Dependent Nephrotic Syndrome

Summary: anti-cd20 agent has been proposed as a rescue therapy for refractory nephrotic syndrome(ns) on the basis of favorable clinical observations. yet the long-term effect on maintaining remission or the likelihood of becoming rituximab-dependent is unclear and the information on the safety profile of rituximab is limited. this trial was designed to investigate the safety and efficacy of rituximab in children with refractory ns.


Eligibility criteria:
inclusion criteria: (a)steroid/calcineurin inhibitor resistant nephrotic syndrome 1. steroid resistance: no remission after 4 weeks of daily oral corticosteroid (60mg/m2/day) 2. calcineurin inhibitor resistance: no remission after 3 months of therapeutic dose administration of cyclosporine and/or tacrolimus 3. no remission defined by persistent proteinuria of nephrotic range for the last 3 months 4. post-transplant patients were included in the study (b)steroid-dependent nephrotic syndrome 1. steroid-dependent patients who had been on various known medications (such as corticosteroids, cyclophosphamide, chlorambucil, calcineurin inhibitors, levamisole ..) continuously for more than 2 years 2. definition of dependency: more than two consecutive relapse events in 2 weeks after discontinuation of steroid or calcineurin inhibitor * no improvement in relapsing frequency with calcineurin inhibitor use * unable to continue with calcineurin inhibitor due to side effects * unable to continue with calcineurin inhibitor due to prolonged use (over 2 years) * other conditions in which the clinician considers difficult to control disease with steroids or calcineurin inhibitors only. exclusion criteria: * previous rituximab use * secondary nephrotic syndrome * estimated gfr \<60ml/min/1.73m2 or under 50% of age-matched standard gfr * chronic or acute active infection (e.g. hepatitis b,c, herpes, varicella zoster) * prior live vaccine inoculation within 1 month (from the study enrollment) * cardiovascular diseases, pulmonary or pleural diseases * uncontrolled hypertension * leukocytopenia (absolute neutrophil count \<1500/mm3) or thrombocytopenia (\<75000/mm3) * pregnancy

Keywords: rituximab nephrotic refractory
prostatic cancer versus androgen deficiency

Conditions: Cancer of Prostate

Summary: open study to make a comparison between hypogonadism and euogonadism patients regarding the severity of prostate cancer. the purpose of this study is to determine the importance of the relationship between the hormonal status and the type of the tumor at the time of surgical intervention as well as follow up of the patients.


Eligibility criteria:
inclusion criteria: * male patients over than 18 years of age, with localized, stage i or ii prostate cancer, not receiving local treatment (radiation, phototherapy, thermotherapy,...) or hormonal therapy, showing indication of radical prostatectomy. exclusion criteria: * absence of radical prostatectomy indication * patient received local or hormonal therapy prior to surgery * patients already enrolled in other clinical study incompatible with the study * patients on a treatment which can affect hormonal level (prednisone, ketoconazole, abiraterone, finasteride, dutasteride)
safety & performance randomized study of the citop™ guidewire for peripheral cto

Conditions: Catheterization, Peripheral

Summary: the main objectives of the study are: to evaluate the performance and safety of the citop guidewire, while attempting to cross thru total occlusions of various dimensions and morphology. to compare the safety and efficacy of the citop guidewire with standard guidewires in terms of impact on the treated artery. following operation of the citop device, angiography demonstrated successful crossing of the occlusion with no visible evidence of arterial wall injury, dissection, or distal embolization. to assess ease of operation and the level of integration of the citop with standard interventional angiography procedure: balloon angioplasty, placement of stent.


Eligibility criteria:
clinical inclusion criteria: * patient with symptomatic peripheral vascular disease, intermittent claudication less than 30 meters, rest pain or tissue ischemia.(fontain grade 3-4) * critical limb ischemia * the patient has chronic total occlusion in limb arteries, aged at least 3 months. * patient has chronic total occlusion (cto) that is: * documented angiographically, by the investigator or co-investigator. * cto was defined as an obstruction of a main peripheral artery with no luminal continuity and with timi (thrombolysis in myocardial infraction) flow grade of 0 or 1. * cto location suitable for endovascular treatment (not in parallel location with the hip or knee joints). * lesion ≤ 8cm in length * lesion located in a segment with diameter more than 1.5 mm * adequate compliance with follow-up and/or repeat angiography * no contra-indication to treatment with aspirin or ticlopidine or clopidogrel and/or heparin * visible entry point of target lesion * no cancer or other life threatening diseases or conditions * no diagnosis or suspected renal failure (2 x uln of creatinine) * not suspected intolerance of the contrast agent * no drug abuse or alcoholism * patients is not under custodial care * women with childbearing potential are not pregnant (positive pregnancy test at the time of procedure).

Keywords: chronic total occlusion
the protective effects of treatment with hyperbaric oxygen prior to bypass heart surgery

Conditions: Myocardial Reperfusion Injury; Cytoprotection

Summary: the purpose of this study was to determine if treating patients who have coronary heart disease with hyperbaric oxygen (hbo) prior to coronary artery bypass graft (cabg) surgery reduces injury to the heart and vascular system during and after surgery. furthermore, this study also aims to identify some of the post cabg clinical effects of hbo treatment prior to cabg.


Eligibility criteria:
inclusion criteria: * patients undergoing elective first time cabg * patients with at least 1 vessel coronary artery disease undergoing on- pump cabg exclusion criteria: * age ≤ 20 years or ≥ 85 years * ejection fraction \< 30% * unstable angina * recent myocardial infarction (\< 1 month) * any additional cardiac disease (e.g. arrythmia, aneurysm, valvular/septal disease, dissection or elevated pulmonary artery pressure) * any end stage organ failure (e.g. renal and respiratory failure) * history of chronic obstructive pulmonary disease (copd) * pneumothorax * pulmonary bullae * convulsions * current history of malignancy * severe myopia or intraocular lens * patients on k+(atp) channel openers e.g. nicorandil, oral hypoglycemics, opioid analgesics, catecholamines.

Keywords: myocardial protection ischemic reperfusion injury hyperbaric oxygen preconditioning
effects of intraoperative esmolol on post-mastectomy pain syndrome

Conditions: Post-mastectomy Pain Syndrome

Summary: chronic postoperative pain is an entity that is usually neglected by anesthetists, but several studies show that the choice of anesthetic technique may interfere with this prevalence. esmolol is a selective beta-blocker of ultra fast duration that has been studied as a perioperative venous adjuvant with antihyperalgesic and opioid sparing action. the investigators ventured the possibility of this anti-hyperalgesic effect attenuating the chronic pain syndrome post-mastectomy.


Eligibility criteria:
inclusion criteria: - patients previously submitted to the study analgesic effect of intraoperative esmolol in mastectomies: a randomized placebo controlled trial exclusion criteria: * patient aged less than 18 years and over 65 years; * patients who refuse to participate in the study; * patients with pulmonary disease; * patients with cardiac, renal or hepatic disease; * use of psychoactive drug; * patients with sinus bradycardia; * pregnant women; * patients with allergy to dipyrone, morphine; * patients with chronic pain prior to the surgical procedure; * patients with neurological disorders; * patients undergoing surgical resurfacing

Keywords: post-mastectomy pain syndrome esmolol perioperative
scar prevention using fractional carbon dioxide laser treatment

Conditions: Scar Prevention

Summary: in this study the investigators intend to determine the impact of fractional co2 laser treatment on the edges of a fresh wound during surgical area closure on thin skin (e.g. face, hands, arms, thorax, etc.) and on thick skin (abdominoplasty procedure) on scar formation. the investigators will also evaluate the effect of shallow fractional laser treatment versus deep parameters settings. if effective treatments could be performed at time of surgery, this would result in both time and cost saving to the patient and to the healthcare system and will improve patient's self-image post surgeries.


Eligibility criteria:
inclusion criteria: * male or females * at least 18 and no more than 65 years old * the surgical area closure in these subjects should be at least 4cm * type of surgery scheduled: site 1: surgical area closure on thin skin, including areas that require motion (e.g. face, hands, arms, thorax, etc.) site 2: surgical area closure on thick skin (abdominoplasty procedure) * willing to comply with study dosing and complete the entire course of the study exclusion criteria: * active bacterial, fungal, or viral infection in the treatment area * active cold sores, or herpes in the treatment area * recent excessive exposure to sunlight or artificial uv light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study * history of skin cancer, unless the surgical procedure of issue is for cancer treatment purposes. * history of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis) * treatment with a systemic retinoid within the past year (e.g., accutane®, roche dermatologics) * history or presenting with a keloid scar * any current or recent treatment for cancer, unless the surgical procedure of issue is for cancer treatment purposes. * any uncontrolled systemic disease. a potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study * significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study. * subject planning any other cosmetic procedure to the study area during the study period, other than the treatments that will be performed by the investigator * female subject who is pregnant, nursing an infant or is less than 6 months after termination of breast feeding * small surgical closure (\<4cm)

Keywords: scar prevention co2 fractional laser
an open-label follow-on trial to assess the long-term safety and efficacy of oral spm 927 in subjects with diabetic neuropathy

Conditions: Painful Diabetic Neuropathy

Summary: the primary objective of the trial is to assess the tolerability and safety of long-term spm 927 administration in subjects with diabetic neuropathy.


Eligibility criteria:
inclusion criteria: * subject has successfully completed a previous trial with spm 927 in diabetic neuropathy and, in the investigator's opinion, would benefit from long-term administration of spm 927. * subject has stable, good or fair diabetic control (hba1c ≤10% ). exclusion criteria: * subject has other conditions that cause neuropathic pain at least as severe as the diabetic pain, i.e. peripheral arterio-vascular disease. * subject receives treatment for seizures. * subject has had an amputation related to diabetes, other than toe amputation. * subject has major skin ulcers. * subject has clinically significant ecg abnormalities. * subject expects to take during the study: tcas, mexiletine hydrochloride, lidoderm patch, tramadol, aeds, dextromethorphan, opioids, capsaicin, skeletal muscle relaxants, benzodiazepines or over-the-counter medications with centrally acting properties. * subject has laboratory values which are outside the normal range and judged by the investigator to be clinically significant. * subject has liver function tests (ast, alt, alkaline phosphatase, total bilirubin, or ggt) ≥ 2x uln at visit 1. * at visit 1, subject has impaired renal function, i.e., creatinine clearance (clcr) is lower than 60 ml/min.

Keywords: lacosamide, vimpat®
evaluation of efficacy of povetacicept in adults with immunoglobulin a nephropathy (igan)

Conditions: Immunoglobulin A Nephropathy

Summary: the purpose of this study is to evaluate the efficacy of povetacicept in adult participants compared with placebo in reducing proteinuria and preserving renal function.


Eligibility criteria:
key inclusion criteria: * diagnosed igan, with biopsy confirmation * 24-hr proteinuria excretion ≥1.0 g/day or 24-hour upcr ≥0.75 g/g * estimated glomerular filtration rate (egfr) ≥ 30 ml/min/1.73m\^2 * stable angiotensin converting enzyme inhibitor (acei) or angiotensin ii receptor blocker (arbs) as per protocol specification key exclusion criteria: * have received any immunosuppressive treatment or procedures (including corticosteroids, oral immunosuppressive agents, b cell or plasma cell targeted therapies, complement targeted therapies, herbal medicines per protocol, and tonsillectomy) within a wash-out period per protocol * rapidly progressive glomerulonephritis with egfr reduction \>50% within 12 weeks of the start of screening other protocol defined inclusion/exclusion criteria may apply.

Keywords: igan berger's disease glomerulonephritis iga nephropathy alpn-303 baff blys april
evaluation of clinical progression in patients with motor predominant parkinson disease.

Conditions: Parkinson Disease

Summary: the objective of this study is the longitudinal prospective clinical evaluation in patients with motor predominant pd; it will assess the individual disease progression (change) of the clinical and imaging parameters measured at 6-month interval over a minimum of 12 months.

the absence of clear pd subtypes defining a common path and rate of disease progression, combined with the absence of validated biomarkers indicative of disease progression and a strong placebo effect, constitute a challenge for clinical trials assessing new potential disease-modifying therapies in pd. the present cohort would constitute a well-defined population of patients, with individual progression assessment, suitable to evaluate new disease-modifying therapies in a subsequent phase1/2 clinical trial.

Eligibility criteria:
inclusion criteria: 1. idiopathic parkinson's disease (according to british brain bank criteria); genetic forms of pd are not excluded 2. male or female adult, aged 70 or less 3. modified hoehn and yahr stage 2 to 3 in off state 4. disease duration, i.e. time from first motor symptoms between 2 to 8 (included) years ; first motor symptoms to be taken into consideration being the cardinal motor symptoms of pd (bradykinesia, tremor and rigidity) 5. univoqual response to l-dopa (of at least 50% in mds-updrs part iii motor score) 6. presence of fluctuations and/or dyskinesia 7. mds-updrs total motor score ≥15 in off state 8. l-dopa treatment stable for at least 4 weeks 9. covered by healthcare insurance 10. written informed consent form signed exclusion criteria: 1. scan without evidence of dopamine deficit (swedd) (datscan) 2. atypical parkinsonism syndrome 3. dementia as detected by a score \< 21/30 at the montreal cognitive assessment screening (moca) 4. psychiatric disorders including major depression with suicidal thoughts as evaluated by a psychiatrist or a neurologist at the selection period 5. any medical or psychological problems which may interfere with a smooth conduction of the study protocol (e.g. cancer with a limited life expectancy) 6. history of significant brain or vascular disease (tumor, epilepsy, stroke ...) 7. any contraindication for undergoing mri of the head 8. prior brain surgical procedures with or without implementation of an intra-cerebral device 9. drug or alcohol addiction 10. pregnancy or breastfeeding 11. patient with reproductive potential who do not agree to use an accepted effective method of contraception - investigator's judgment- during the study period 12. illiteracy or insufficient language skills (french) to complete the questionnaires 13. patient deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection (e.g. guardianship or curatorship). 14. simultaneous participation in another clinical trial with the administration of investigational drug(s)